Azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia

Review Decision - April 2014 information

Appendix A: decision paper presented to the Institute's Guidance Executive

Appendix A: decision paper presented to the Institute's Guidance Executive (PDF 102 KB)

Review Proposal - February 2014 information

TA218- Azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia - Appendix A - provisional matrix of stakeholders

TA218- Azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia - Appendix A - provisional matrix of stakeholders (PDF 97 KB)

TA218 - Azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia - Appendix B - proposal paper presented to the Institute's Guidance Executive

TA218 - Azacitidine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia - Appendix B - proposal paper presented to the Institute's Guidance Executive (PDF 257 KB)

TA218 Myelodysplastic syndromes - azacitidine: press release information

Download PDF version

Myelodysplastic syndromes - azacitidine: equality impact assessment

Myelodysplastic syndromes - azacitidine: final appraisal determination 2  information

Myelodysplastic syndromes - azacitidine: final appraisal determination

Myelodysplastic syndromes - azacitidine: final appraisal determination (PDF 186 KB)

Myelodysplastic syndromes - azacitidine: response to consultee, commentator and public comments on the ACD and comments from website consultation

Myelodysplastic syndromes - azacitidine: response to consultee, commentator and public comments on the ACD and comments from website consultation (PDF 89 KB)

Myelodysplastic syndromes - azacitidine: consultee and commentator comments on the ACD

Myelodysplastic syndromes - azacitidine: Celgene

Myelodysplastic syndromes - azacitidine: Celgene (PDF 63 KB)

Myelodysplastic syndromes - azacitidine: MDS UK Patient Support Group

Myelodysplastic syndromes - azacitidine: MDS UK Patient Support Group (PDF 269 KB)

Myelodysplastic syndromes - azacitidine: Royal College of Nursing

Myelodysplastic syndromes - azacitidine: Royal College of Nursing (PDF 59 KB)

Myelodysplastic syndromes - azacitidine: Royal College of Pathologists and the British Society for Haematology

Myelodysplastic syndromes - azacitidine: Royal College of Pathologists and the British Society for Haematology (PDF 79 KB)

Myelodysplastic syndromes - azacitidine: Royal College of Physicians on behalf of NCRI/RCP/RCR/ACP/JCCO

Myelodysplastic syndromes - azacitidine: Royal College of Physicians on behalf of NCRI/RCP/RCR/ACP/JCCO (PDF 46 KB)

Myelodysplastic syndromes - azacitidine: Department of Health

Myelodysplastic syndromes - azacitidine: Department of Health (PDF 74 KB)

Myelodysplastic syndromes - azacitidine: Decision Support Unit review of Celgene's response to the post appeal ACD

Myelodysplastic syndromes - azacitidine: appraisal consultation

Myelodysplastic syndromes - azacitidine: appraisal consultation document information

Myelodysplastic syndromes - azacitidine: additional information submitted by Celgene

Myelodysplastic syndromes - azacitidine: additional information submitted by Celgene (PDF 478 KB)

Myelodysplastic syndromes - azacitidine: critique of additional information by the Decision Support Unit (DSU)

Myelodysplastic syndromes - azacitidine: Decision Support Unit specification

Myelodysplastic syndromes - azacitidine: Decision Support Unit specification (PDF 64 KB)

Myelodysplastic syndromes - azacitidine: report by the Decision Support Unit

Myelodysplastic syndromes - azacitidine: report by the Decision Support Unit (PDF 132 KB)

Myelodysplastic syndromes - azacitidine: addendum to the Decision Support Unit report

Myelodysplastic syndromes - azacitidine: appeal decision

Myelodysplastic syndromes - azacitidine: appeal announcement information

Celgene Ltd

Appeals received

Appeals received (PDF 1.03 MB)

Initial scrutiny letter

Initial scrutiny letter (PDF 128 KB)

Response to scrutiny letter

Celgene response to initial scrutiny letter

Celgene response to initial scrutiny letter (PDF 179 KB)

Celgene appeal letter amended

Celgene appeal letter amended (PDF 373 KB)

Final scrutiny letter

Final scrutiny letter (PDF 93 KB)

Response to final scrutiny letter

Response to final scrutiny letter (PDF 147 KB)

Response to Celgene's final letter

Response to Celgene's final letter (PDF 75 KB)

Royal College of Pathologists and British Society of Haematology

Appeals received

Appeals received (PDF 85 KB)

Initial scrutiny letter

Initial scrutiny letter (PDF 85 KB)

Response to scrutiny letter

Response to scrutiny letter (PDF 68 KB)

Final scrutiny letter

Final scrutiny letter (PDF 69 KB)

MDS Patient Support Group, Leukaemia Society and Rare Cancer Forum

Appeals received

Appeals received (PDF 725 KB)

Initial scrutiny letter

Initial scrutiny letter (PDF 90 KB)

Response to scrutiny letter

Response to scrutiny letter (PDF 609 KB)

Final scrutiny letter

Final scrutiny letter (PDF 76 KB)

Response to final scrutiny letter

Response to final scrutiny letter (PDF 627 KB)

Response to final letter

Response to final letter (PDF 69 KB)

Royal College of Physicians, Medical Oncology Joint Special Committee

Appeals received

Appeals received (PDF 123 KB)

Initial scrutiny letter

Initial scrutiny letter (PDF 84 KB)

Response to scrutiny letter

Response to scrutiny letter (PDF 121 KB)

Final scrutiny letter

Final scrutiny letter (PDF 68 KB)

Ground 3 - Human Rights appeal point

Appeal Panel's legal advisors document

Appeal Panel's legal advisors document (PDF 125 KB)

Celgene's response

Celgene's response (PDF 120 KB)

MDS UK's response

MDS UK's response (PDF 640 KB)

Appraisal Committee observations

Myelodysplastic syndromes - azacitidine: final appraisal determination information

Myelodysplastic syndromes - azacitidine: final appraisal determination

Myelodysplastic syndromes - azacitidine: final appraisal determination (PDF 117 KB)

Myelodysplastic syndromes - azacitidine: response to consultee, commentator and public comments on the ACD

Myelodysplastic syndromes - azacitidine: response to consultee, commentator and public comments on the ACD (PDF 151 KB)

Myelodysplastic syndromes - azacitidine: consultee and commentator comments on the ACD

Celgene - ACD response

Celgene - ACD response (PDF 688 KB)

Celgene - letter about Patient Access Scheme

Celgene - letter about Patient Access Scheme (PDF 32 KB)

MDS UK Patient Support Group, Rarer Cancers Forum, Leukaemia CARE, Leukaemia Research Fund, Leukaemia Society and Macmillan Cancer Support

MDS UK Patient Support Group, Rarer Cancers Forum, Leukaemia CARE, Leukaemia Research Fund, Leukaemia Society and Macmillan Cancer Support (PDF 137 KB)

Royal College of Nursing

Royal College of Nursing (PDF 6.9 KB)

Royal College of Pathologists (RCPath) and the British Committee for Standards in Haematology (BCSH)

Royal College of Pathologists (RCPath) and the British Committee for Standards in Haematology (BCSH) (PDF 75 KB)

Royal College of Physicians and Professor David Bowen on behalf of NCRI/RCP/RCR/ACP/JCCO)

Royal College of Physicians and Professor David Bowen on behalf of NCRI/RCP/RCR/ACP/JCCO) (PDF 19 KB)

Department of Health

Department of Health (PDF 7.8 KB)

Stockton PCT

Stockton PCT (PDF 118 KB)

Welsh Assembly Government

Welsh Assembly Government (PDF 7 KB)

West London Cancer Network on behalf of Harrow PCT

West London Cancer Network on behalf of Harrow PCT (PDF 17 KB)

Harford

Harford (PDF 11 KB)

Myelodysplastic syndromes - azacitidine: clarification request to Celgene, Celgene's response and ERG and DSU critique

Committee request to Celgene for clarification on their Appraisal Consultation Document response

Committee request to Celgene for clarification on their Appraisal Consultation Document response (PDF 36 KB)

Further clarification request to Celgene

Further clarification request to Celgene (PDF 45 KB)

Celgene's consolidated response to all clarification requests

Celgene's consolidated response to all clarification requests (PDF 268 KB)

ERG critique of Celgene's response the Appraisal Consultation Document

ERG critique of Celgene's response the Appraisal Consultation Document (PDF 484 KB)

Addendum to ERG critique of Celgene's response to the Appraisal Consultation Document

Addendum to ERG critique of Celgene's response to the Appraisal Consultation Document (PDF 44 KB)

Decision Support Unit report

Myelodysplastic syndromes - azacitidine: update to consultee and commentators

Myelodysplastic syndromes - azacitidine: appraisal consultation

Myelodysplastic syndromes - azacitidine: appraisal consultation document information

Myelodysplastic syndromes - azacitidine: evaluation report

Pre-meeting briefing

Pre-meeting briefing (PDF 277 KB)

Evidence Review Group report

Evidence Review Group report (PDF 267 KB)

Addendum Evidence Review Group Report

Addendum Evidence Review Group Report (PDF 521 KB)

Non-manufacturer submissions

Leukaemia Society (UK) and MDS Patient Support Group

Leukaemia Society (UK) and MDS Patient Support Group (PDF 51 KB)

Rarer Cancers Forum

Rarer Cancers Forum (PDF 46 KB)

Royal College of Nursing

Royal College of Nursing (PDF 12 KB)

Royal College of Pathologists

Royal College of Pathologists (PDF 39 KB)

Royal College of Physicians (on behalf of National Cancer Research Institute/Royal College of Radiologists/Joint Collegiate Council for Oncology/Association of Cancer Physicians)

Royal College of Physicians (on behalf of National Cancer Research Institute/Royal College of Radiologists/Joint Collegiate Council for Oncology/Association of Cancer Physicians) (PDF 44 KB)

Manufacturer submission

Manufacturer submission

Manufacturer submission (PDF 2.02 MB)

Appendix - Estimation of utilities for health states associated with different treatments for myelodyplastic syndrome (MDS)

Appendix - Estimation of utilities for health states associated with different treatments for myelodyplastic syndrome (MDS) (PDF 446 KB)

Expert written personal statements

Bowen

Bowen (PDF 24 KB)

Culligan

Culligan (PDF 59 KB)

Harford

Harford (PDF 17 KB)

Pendleton

Myelodysplastic syndromes - azacitidine: final matrix of consultees and commentators

Myelodysplastic syndromes - azacitidine: final scope

Myelodysplastic syndromes - azacitidine: comments on the draft matrix

Myelodysplastic syndromes - azacitidine: draft matrix of consultees and commentators

Myelodysplastic syndromes - azacitidine: comments on the draft scope

Myelodysplastic syndromes - azacitidine: draft scope